Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: N/A
Principal Investigator: Vose, Julie
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/study/NCT05041309?term=NCT05041309&draw=2&rank=1#eligibility
Summary
Primary Objectives
Evaluate the incidence and severity of late-onset targeted AEs/serious AEs (SAEs) suspected to be possibly related to gene-modified cells, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and secondary malignancies Evaluate mechanism of RCR/RCL and/or insertional mutagenesis for confirmed events
related to the cell therapy product Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects
treated with gene-modified cells
Secondary Objectives
Determine the time to next treatment after administration of gene-modified cells in the completed parent study
Determine survival status
Determine cause of death
Evaluate immune reconstitution
Evaluate the incidence of RCR/RCL
Exploratory Objectives
Evaluate the levels of genetically-modified cells in blood
Determine the status of the primary malignant disease
Evaluate pregnancy outcomes in females of childbearing potential